Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show the points to be off from the physical reference point of the pointer or suction.
Stryker Leibinger GmbH & Co. KG
25 recalls • • Categories: Surgical Instruments, Other Medical Devices, Implants & Prosthetics, Diagnostic Equipment
Class I - Dangerous
Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure
Class I - Dangerous
Device was shipped without having regulatory approval.
Class I - Dangerous
Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the superior side.
Inability for the user to inject the paste from the syringe into the target location.
Class I - Dangerous
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Class I - Dangerous
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Class I - Dangerous
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Class I - Dangerous
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Class I - Dangerous
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Class I - Dangerous
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Class I - Dangerous
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Class I - Dangerous
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Class I - Dangerous
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Class I - Dangerous
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Class I - Dangerous
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Class I - Dangerous
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Class I - Dangerous
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Class I - Dangerous
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Class I - Dangerous
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Class I - Dangerous
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
An incorrect sterility status on the label, non-sterile products labeled as sterile
Class I - Dangerous
An incorrect sterility status on the label, non-sterile products labeled as sterile